Product code SHJ— Anesthesiology

Helo Return

Classification name: Thrombectomy Whole Blood Return System
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Total cleared: 1
First cleared: 2026-10-11
Most recent: 2026-10-11

FDA classification definition

“Filtration and return of aspirated whole blood during a thrombectomy procedure”
— U.S. Food and Drug Administration, device classification record for product code SHJ under 21 CFR 868.5830, via openFDA

Market context for product code SHJ

FDA has cleared 1 device under product code SHJ, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SHJ

Endovascular Engineering, Inc.1 clearance

Recent clearances under product code SHJ

K253717 — Helo ReturnEndovascular Engineering, Inc.·2026-10-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.